The latest updates to Practical Law’s Life Sciences Global Guide feature two revised sections from Tilleke & Gibbins attorneys in the firm’s Jakarta office—“Medicinal Product Regulation and Product Liability in Indonesia,” and “Pharmaceutical IP and Competition Law in Indonesia.”
“Medicinal Product Regulation and Product Liability in Indonesia” covers a range of regulatory issues related to the marketing and selling of pharmaceutical products, including the following:
- Regulatory overview, including relevant laws and authorities, scope, definitions, and general procedures for pharmaceuticals, biologicals, and medical devices and health care IT
- Pricing, government funding, and reimbursement: Structure of Indonesia’s health care system, price regulation, and reimbursement
- Clinical trials
- Manufacturing and distribution
- Marketing: Authorization for marketing medicinal products, parallel imports and cross-border trade in medicines
- Restrictions on dealings with health care professionals
- Selling restrictions
- Advertising and promotion
- Data privacy
- Packaging, labeling, and tracking
- Product safety, quality, and liability
- Local establishment, representation, and residency requirements
- Reform
The full “Medicinal Product Regulation and Product Liability in Indonesia” section can be accessed on the Practical Law website.
“Pharmaceutical IP and Competition Law in Indonesia” first goes over the country’s legal and regulatory environment for patents and trademarks in relation to pharmaceutical business operations in the jurisdiction. The section then turns to competition law issues, with the Q&A format focusing on how the country’s competition laws and regulations affect the pharmaceutical sector. Readers are also given information on how to properly comply with Indonesian competition law, including in the licensing of medicines and pharmaceutical technology.
The full “Pharmaceutical Intellectual Property and Competition Law in Indonesia” section can be found on the Practical Law website.
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